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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1514942
Application of Global Trigger Tool to determine the prevalence of adverse drug reactions in adult patients admitted to general and COVID-19 intensive care units
Provisionally accepted- State University of Campinas, Campinas, Brazil
Objective: The primary aim of this study was to determine the prevalence of ADRs in adult patients admitted to a general adult intensive care unit (G-ICU) and a COVID-19 adult intensive care unit (C19-ICU). The secondary aims were to characterize ICU patients; identify factors associated with ADRs; evaluate trigger performance; describe ADRs by severity, mechanism, causality, and suspected drugs; and compare the trigger tool with spontaneous reporting.Methods: This was a descriptive and retrospective study that applied triggers adapted from the GTT to identify ADRs in adult patients admitted to the G-ICU and C19-ICU of a tertiary hospital (HES), from January to December 2020. The patients were characterized by sex, age, length of stay, clinical outcome (discharge or death), and SOFA scores. The performance of triggers in detecting ADRs was determined by calculating PPV. ADRs were characterized by severity, mechanism, causality, and suspected drugs. The spontaneous reporting database at the HES was analyzed, and ADRs from the ICUs were identified.Results: The study evaluated 135 patients, with a predominance of males (54.8%) and a mean age of 61.0 ± 15.1 years. The mean hospital stay was 13.0 ± 11.0 days, the average SOFA score throughout hospitalization was 8.4 ± 3.8, and the ICU mortality rate was 69.6%. Of the 135 admitted patients, 55 (40.7%) presented with at least one ADR. The length of hospitalization was associated with the presence of ADR in both ICUs studied and age only in the C19-ICU. Additionally, patients admitted to the C19-ICU had a 2.4 times higher risk of developing ADRs. A total of 85 ADRs were identified, 65 (76.5%) of which occurred through triggers. The triggers with the best performance in detecting ADRs, with a PPV of 100%, were ‘Partial Thromboplastin Time > 50’, ‘Skin Rash’, ‘Protamine’, and ‘Hydroxyzine’. Most ADRs were moderate (56.5%), Type A (96.5%), and classified as possible (64.7%). Insulin was the drug most frequently associated with ADRs. Only five ADRs in ICU patients were spontaneously reported in 2020.Conclusion: ADR occurrence was 40.7%, with the trigger tool identifying significantly more cases than spontaneous reporting, highlighting its effectiveness in strengthening pharmacovigilance.
Keywords: Pharmacovigilance, Intensive Care Unit, Adverse Drug Reaction, trigger tool, COVID-19
Received: 21 Oct 2024; Accepted: 18 Mar 2025.
Copyright: © 2025 Nogueira De Souza and Moriel. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Patricia Moriel, State University of Campinas, Campinas, Brazil
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